Be aware that comparative effectiveness studies with two active treatment arms will be necessary to evaluate whether this agent should be routinely used in the treatment of MS symptoms.

PHILADELPHIA -- A long-lasting version of a multiple sclerosis drug improved walking and balance, a researcher said here.

In a randomized placebo-controlled trial, dalfampridine extended release (Ampyra) sustained the improvements over 6 months, according to Jan Lycke, MD, PhD, of the University of Gothenburg in Sweden.

The findings, from an industry-sponsored study, extended previous research over a longer study period and broader range of measures, Lycke said at the annual meeting here of the American Academy of Neurology.

In addition, he told an oral session, the proportion of patients with treatment-emergent adverse reactions was similar between treated and placebo patients.

Two previous trials, he noted, have shown that the drug (known as fampridine, or Fampyra, outside the U.S.) leads to better scores on the Timed 25-Foot Walk test. But that test, he noted, might not evaluate all aspects of walking.

To get a broader picture, Lycke and colleagues studied outcomes in 132 patients with either relapsing/remitting or progressive disease and an Expanded Disability Status Scale (EDSS) score of between 4.0 and 7.0.

Patients were evaluated using the 12-item MS walking scale, the Timed Up and Go (TUG) test, the Berg Balance Scale, the 29-item MS impact scale (MSIS-29), and the EuroQOL 5-dimensions 5-level instrument.

Patients on the drug showed greater median improvements than placebo patients on all measures except the EuroQOL instrument, Lycke said -- a gain of 6.92 points versus a loss of 2.89 points on the walking scale, a 12.26% increase in TUG speed versus 3.49%, a gain of 2.93 points versus 1.71 points on the balance scale, and a decrease of 4.96 points on the MSIS-29 physical subscale, compared with a loss of 2.19.

Also, he said, more treated patients had clinically meaningful improvements on the MS walking scale and the TUG test. Specifically:

And 47.1% improved their TUG speed by at least 15%, compared with 30.2% of those on placebo (P=0.026).

On the other hand, the size of the benefit was relatively modest, perhaps because of the range of patients included in the study, according to Janice Wiesman, MD, of the Boston University School of Medicine, who was not part of the study.

There are important differences between patients with disability scores of 4.0 and 7.0, while relapsing/remitting patients differ from those with progressive disease, she told MedPage Today.

"Maybe you could say that the fact that there was a positive result at all shows that the drug works well," she said, "because it was really tested in a disparate group."

She added that the 132 patients are a relatively small group who were randomized from 24 sites in six countries, "introducing a lot of noise into the study."

"So again, maybe the fact it shows significance at all is kind of wow," she said.

If research continues to show it works, she said, the drug would be attractive because it would be more convenient for patients, which might improve drug compliance and outcomes.

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